National Comprehensive Cancer Network

Educational Events & Programs

The Oncology Research Program

The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) has developed a successful model to support the research enterprise at NCCN Member Institutions and to facilitate the post-approval evaluation of innovative and promising therapies. The Research Grant Model identifies significant research issues in collaboration with participating pharmaceutical and biotechnology companies and then facilitates investigator-initiated clinical research in those specific areas at NCCN Member Institutions.

The Research Grant Model (Investigator Initiated Trials)

The Research Grant Model facilitates Preclinical and Clinical Phase I and Phase II investigator initiated research by:

• Identifying specific research questions
• Organizing expert teams to develop Request for Proposals (RFPs)
• Soliciting proposals for clinical trials
• Evaluating and prioritizing those proposals
• Funding the most promising proposals
• Supervising the implementation and accrual of the clinical trials
• Disbursing grant funds according to achievement of important benchmarks
• Supporting the publication of results of the studies

The goal of the program is to explore new avenues of clinical investigation that answer important scientific questions and improve patient care. Studies evaluate new combinations of drugs, mechanisms of action of specific agents, drug resistance, or explore extended uses for specific agents.

Research Grant Model Functions

The NCCN ORP performs the following functions for implementation of the Research Grant Model:
 
Project Advisory Teams (PATs): NCCN establishes PATs consisting of expert faculty from NCCN Member Institutions to guide development of research projects of interest. The PATs focus on formulating the project around the research priorities established based upon a collaborative review of available data by the PAT and the Grantor.  Advisory Team members specialize in the research areas of interest to oversee the development of RFPs which elicit proposals that yield studies of high scientific and clinical value.

The Advisory Team also includes a Grantor representative or representatives, appointed by the Grantor. The Grantor representative(s) serves in an advisory capacity and participates in meetings on an as-needed basis at Grantor’s discretion.

The Grantor is provided with the RFPs for review, input, and agreement regarding the intended approval before RFPs are finalized and circulated.

Request for Proposals (RFPs):  RFPs request short (6-8) page proposals for studies related to the Grantor Product and related research areas of interest. The RFPs clearly state that the NCCN Member Institutions conducting funded trials will be responsible for the data management, statistical analysis, safety reporting and quality assurance process associated with the research. The RFPs require a reasonably detailed description of how these responsibilities will be managed for single center and multicenter trials. The RFPs also require that the proposals include a scientific rationale, a proposed study design that includes a description of the study, the population to be studied, treatment plans, endpoints, a preliminary statistical evaluation plan, a feasibility plan detailing the availability of patients and/or plans for collaboration with other NCCN Member Institutions, and a proposed budget.

Preparation of Proposals by NCCN Investigators:  NCCN sends notification of RFPs to designated senior investigators at each NCCN Member Institution who are responsible for its distribution. In addition, NCCN sends announcements of the RFPs to public relations and grants and contracting representatives at NCCN Member Institutions. The PATs require an eight (8) week response cycle from the time of such notification to the due date for the submission of proposals.

Scientific Review and Selection - Scientific Review Committee:  NCCN establishes a qualified Scientific Review Committee (SRC) to review and evaluate all of the study proposals that are received in response to the RFPs. Each of the SRC members are from NCCN Member Institutions and have an appropriate level of expertise in the designated therapeutic area.  

The SRC review for each proposal is a formal process consisting of major reviews by at least two (2) members of the SRC with discussion and ranking by all members of the SRC. The Grantor has the option, but is not required, to participate in the SRC meetings and review activities.

The Grantor serves in an advisory capacity to the SRC. The Grantor is given the opportunity to review, each of the proposals that the SRC is intending to recommend for approval.  The Grantor  has the right to recommend disapproval of a particular proposal if that proposal is based upon research projects, protocols or designs that duplicate already well-studied concepts, or that raise potential scientific or safety concerns.

Basic Science Research Project/Clinical Protocol Development and Initial Approval:  All investigators selected develop a research plan or protocol based upon the approved study proposals. The research project(s) or protocol(s) are evaluated by ORP medical staff to ensure conformity to the study plan delineated in the approved proposal.

NCCN ensures that all necessary regulatory requirements, including IRB approval of the protocol, are properly documented, contracting is completed, and appropriate regulatory documentation is fully in place before any funds and study drug are released.

The Grantor is given the opportunity to review  each final research project or protocol approved for funding, along with its proposed budget, for conformance with its investigator initiated trial guidelines.

NCCN is the sponsor of all of the involved studies, and requires that the selected NCCN Member Institution investigators are responsible for conducting the studies according to Good Clinical Practice Guidelines or the Animal Welfare Act (as applicable) and all applicable laws and regulations related to both human and animal research. 

Investigators obtain and maintain an Investigational New Drug (IND) if required, Institutional Review Board (IRB) or Institutional Animal Care and Use Committee (IACUC) review and approval, written informed consents, and written authorizations to use personal health information in research. If acceptable to the Grantor, investigators are encouraged to cross-reference the Grantor’s IND.

NCCN informs the Grantor of any proposed changes to research projects or protocols prior to their implementation that may affect the administration and/or use of the Grantor’s product (e.g., dosage, duration of treatment), the study objectives, or subject safety.  

NCCN ensures that all studies that are approved for funding by the SRC are commenced within the following specific periods (depending on the type of study that is involved):

• preclinical studies are commenced no later than six (6) months after the Member Institution is provided with notice of the approval by NCCN.  However, investigators are encouraged to commence studies within 3-6 months after notice of approval;
• clinical studies are commenced no later than nine (9) months after the Member Institution is provided with notice of the approval by NCCN.  However, investigators are encouraged to commence clinical studies within 6-9 months after notice of approval.

If an approved study is not commenced within the applicable time period it is no longer considered an approved study and the project concept must be resubmitted to NCCN for a new review and approval. In addition, all funding supplied by NCCN to a Member Institution for a study that does not commence within the applicable specified time period must be returned to NCCN by the Member Institution.

Adverse Events:  Member Institutions and investigators agree to promptly report serious and other adverse events associated with the use of the Grantor’s product to the FDA, NCCN, and the Grantor according to all applicable regulations and requirements. It is the responsibility of each involved Member Institution's Data Safety and Monitoring Committee to review all adverse events and issue adverse event reports to the IRB, FDA, and Grantor in accordance with the applicable regulations, requirements and institutional policies.

ORP Monitoring:  NCCN monitors the status and progress of all funded studies performed at least once every three months during the term of the project. Monitoring includes an assessment of total enrollment, eligibility and evaluability. NCCN, through ORP, refers studies not meeting NCCN's general criteria to the SRC for discussion with the study investigator and implementation of remedial steps (which may include termination of the involved study).   

NCCN/ORP Reporting:  NCCN provides to Grantor on a quarterly basis detailed and written status reports. These status reports address:

1. the number of RFPs solicited and considered during the current reporting period as well as an aggregate count of same for the life of the project up to that point in time;
2. the number of studies/projects that were approved during the current reporting period and to whom they were awarded as well as an aggregate count of same for the life of the project up to that point in time;
3. the current status of each approved study or project at the time of the close of the current reporting period;
4. the amount of grant payments made during the current reporting period for each approved study or project as well as an aggregate amount for the life of the project up to that point in time and;
5. NCCN/ORP administration costs.

Investigator Meeting:  On an annual basis, funded investigators meet to present their findings. The purpose of these meetings is to share results and generate hypotheses for future studies to be conducted. The agenda for each meeting is determined by NCCN in collaboration with the Grantor’s scientific staff, in order to maximize:

1. the interchange of information between NCCN and Grantor;
2. the utility of such meetings. 

NCCN plans, schedules, and facilitates these meetings.

Publication of Study Results:  Principal Investigators are encouraged to publish the results relating to each approved study. NCCN provides Grantor with a copy of any proposed manuscript or abstract for review.   The Grantor may request that publication and disclosure of the manuscript or abstract to any third party be delayed for an agreed upon additional period of time so that the Grantor can seek patent protection of existing or potential intellectual property rights. 

Grant Disbursements:  NCCN makes study funding disbursements to the selected Member Institutions for individual research studies conducted as follows:

1. Research Projects (Basic Research):
• 50% upon approval of funding
• 35% upon completion of research and receipt of final report by NCCN
• 15% upon submission of article for publication
2. Phase I trials:
• 25% after IRB approval and implementation
• Based on the per subject costs (after the initial 25% of funding has been accounted for) and based on subject accrual, funds will be provided on a quarterly basis for eligible subjects enrolled on a study, based on the per subject rate up to a maximum of 85% of the funding
• 15% of funds will be provided after submission of a manuscript for publication
3. Phase II trials and correlative studies:
• 25% after IRB approval and implementation
• 30% after 50% subject accrual
• 30% after 100% subject accrual
• 15% of funds will be provided after submission of a manuscript for publication